The Guideline Language and Format Instrument (GLAFI): development process and international needs assessment survey

Background Successful guideline implementation depends both on factors extrinsic to guidelines and their intrinsic features. In the Guideline Implementability for Decision Excellence Model (GUIDE-M), “communicating” content (language and format) is one of three core determinants of intrinsic implementability, but is seldom addressed. Our aims were to develop a tool that could be used by guideline developers to optimize language and format during development; identify gaps in this type of guidance in existing resources; and evaluate the perceived need for and usefulness of such a tool among guideline developers. Methods Our mixed-methods design consisted of (1) content development (selection and organization of evidence-based constructs from the GUIDE-M into a prototype Guideline Language and Format Instrument (GLAFI), followed by face validation with guideline developers); (2) document analysis (duplicate) of seven existing guideline tools to measure coverage of GLAFI items and identify new items; and (3) an international survey of guideline developers (corresponding authors of recent Canadian Medical Association or Guidelines International Network database guidelines) to measure perceived importance of language and format, quality of existing resources, and usefulness of a language and format tool. Results GLAFI items were organized into 4 language and 4 format subdomains. In face validation with guideline developers (17 clinicians, 1 methodologist), all agreed that the tool would improve guideline implementability and 93% indicated a desire for regular use. In the existing guideline tool document analysis, only 14/44 (31.8%) GLAFI items were operationalized in at least one tool. We received survey responses from 148/674 (22.0%) contacted guideline authors representing 45 organizations (9 countries). Language was rated as “extremely important” or “important” in determining uptake by 94% of respondents, and format by 84%. Correspondingly, 72% and 70% indicated that their organization would likely use such a tool. Conclusions Optimal language and format are fundamental to guideline implementability but often overlooked. The GLAFI tool operationalizes evidence-based constructs, most of which are absent in existing guideline tools. Guideline developers perceive these concepts to be important and express a willingness to use such a tool. The GLAFI should be further tested and refined with guideline developers and its impact on end-users measured. Supplementary Information The online version contains supplementary material available at 10.1186/s13012-022-01219-2.

Avoid recommendations requiring many steps, multiple action types, and/or many different conditional factors influencing performance NA Limit the number of distinct elements (e.g. conditions) or alternatives provided in a recommendation Ideally, use no more than 3 items or conditions within a recommendation 1-3 ; 5 should be the limit. If exceeding 5 conditions, use formatting tools such as bullets (see Format section) 4 .
Use conditional statements (if, then or if, then, else) to reduce complexity 5 For example: We recommend that the initial test for ischemic heart disease in patients with LBBB or ventricular paced rhythm should be either vasodilator stress myocardial perfusion imaging or cardiac CT angiography. Improved Statement: If a patient has a LBBB or ventricular paced rhythm, then we recommend vasodilator stress myocardial perfusion imaging or cardiac CT angiography for initial ischemic heart disease testing.
Limit any checklists to 5 to 7 items to optimize memory 6 NA 2. LANGUAGE: Clear 2a. Actionable/Effective writing: An actionable recommendation is one which provides clear instructions on the action to be undertaken, and the level of certainty with which it is being recommended. It also ensures proper grammar and tone (active voice) to optimize the efficiency of messages.
r r Use the active voice to make instructions more actionable Employ consistent use of a letter, number, and/or symbol system for characterizing both the strength of a recommendation and the quality of evidence Recommendations can be identified as Strong (Level 1) or Weak (Level 2) Weak (Level 2) recommendations can alternatively be described using terms such as: conditional (depending on patient values, resources available, and/or setting) discretionary (based on opinion of patient or practitioner) qualified (by an explanation regarding the issues which would lead to different decisions) For weak recommendations, the GRADE working group has suggested less definitive wording, such as "we suggest..." or "clinicians might..." or "We conditionally recommend…" or "We make a qualified recommendation that…" For strong recommendations, the GRADE working group has suggested terms such as: We recommend or "clinicians should...", "clinicians should not…" or "Do…", "Don't…" To convey the strength of a recommendation the GRADE working group recommends using either a number (e.g. "1" for a strong recommendation) or a symbol (e.g. ↑↑ for a strong recommendation).
The Guideline Language and Format Instrument (GLAFI) Copyright Ó 2021: Gupta S and Kastner M To convey quality of evidence, use either a letter (e.g. "A" for high quality) or a symbol (e.g. ⨁⨁⨁⨁ for high quality) Specific: Vagueness occurs when the boundaries of a word's meaning are not well defined; use of specific, concrete statements increases the extent to which information is both understood and remembered. Who is responsible for completing the action in a given recommendation and for whom [i.e. for which exact patients it should (and/or should not) be completed] 8 State under what specific conditions or circumstances (e.g., when and where) the action is to be performed (if more than one might apply) (e.g. clinical setting, given specific laboratory results, etc.) 9 List exclusions: Circumstances where the action should not be performed (i.e. specific cases requiring an exception to be made) 10 r r Avoid "weasel" words (vague and under-specified words or phrases)

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Avoid syntactic ambiguity (ambiguity caused by the structure of syntax such as lack of punctuation, especially when using Boolean connectors) 13 Use Boolean connectors (AND / OR / NOT) along with appropriate punctuation: For the statement:

"A or B and C", specify if this means (A or B) and C versus A or (B and C)
r r Avoid pragmatic ambiguity (when guidance is not pragmatic because two or more recommendations within a guideline conflict with one another or a recommendation does not include instructions for common clinical scenarios) 13 Ensure: that two or more recommendations within a guideline addressing overlapping actions, target populations, and/or conditions are consistent with one another. If a specific recommendation or set of recommendations excludes a commonly encountered clinical scenario (i.e., target population and/or conditions): attempt to provide guidance for the missing clinical scenario (if required, acknowledge the lack of evidence for that scenario and provide consensus guidance) 2b. Consistent use of Terms: Ensure that the same terms are used across recommendations whenever possible, and that these terms are used consistently (i.e. to indicate the same meaning).

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Use the same semantic indicators (use the same terminology to indicate level of evidence, strength of recommendation, and the same action verbs) across recommendations NA r r When comparing alternative approaches, frame the recommendations in favor of a particular management approach rather than against an alternative For example, avoid: "In patients with asthma who have suboptimal control (defined as X) on ICS monotherapy, we recommend switching to ICS/LABA therapy, and not doubling the ICS dose." Use: "…"In patients with asthma who have suboptimal control (defined as X) on ICS monotherapy, we recommend switching to ICS/LABA rather than doubling the ICS dose." r r Reserve use of "not" for recommendations against a management approach that may be particularly harmful and/or widespread An example of appropriate use: "We recommend not initiating inhaled corticosteroids in patients with COPD who have a low symptom burden (mMRC ≤1 and CAT < 10) and are at a low risk for exacerbations (≤ 1 moderate exacerbation and no severe exacerbation in 12 months)." r r When justifying a recommendation, place emphasis on the beneficial outcomes to be gained from adopting the recommendation (as opposed to the deleterious effects of not adopting it) [14][15][16] NA 3b. Relative advantage: Behaviour change Is most likely when the reader Is effectively convinced of the advantage of the newly recommended practice over the existing one. r r When a recommendation calls to change a previous, established practice to a new practice, conceptualize the benefits of the new practice over the previous one in multiple domains (where possible) 16,17 Present the benefits of the new practice in terms of: • Improved patient outcomes • Economic benefits (from the patient, clinician, and/or system perspective) • Peer acceptance • Ease of use Provide language: which recognizes and attempts to mitigate any limitations to adopting the new practice resulting from limited existing resources *Applies to guideline text other than recommendation alone (e.g. explanatory material around recommendations) The Guideline Language and Format Instrument (GLAFI) Copyright Ó 2021: Gupta S and Kastner M

FORMAT: Components
Standardized components: Including certain standardized components in guidelines can increase the ease of access for guideline users. r r Ensure that the following components are included in the guideline 18-20 : • Executive summary of key recommendations -the summary should provide information on where to find more extensive explications in the guideline • A clear display of the logos of all involved organizations 21 • A structured abstract • A glossary of defined terms (particularly when terms are not commonly used or when common usage varies or is imprecise) • An algorithm and/or summary capturing the major recommendations considered essential to the whole guideline 22,23

FORMAT: Presentation
Document layout: Visual elements and information should be placed and arranged optimally and consistently for ease of interpretation and recall. r r Place pictorial elements (e.g. tables/graphs/flowcharts) on the left-hand side of documents, and text on the right for ease of interpretation and recall 24,25 ** NA Document structure: Structure relates to the high-level categorization of the components of a recommendation and how recommendations relate to each other. 26,27 . When guidelines are structured in a sequence that mimics the real patient encounter, using real-world conventions, clinicians assimilate the information better. 28 r r Ensure that the guideline has a clearly identifiable and optimal structure** 26 Headings should: • Be numbered and named appropriately to convey the message in each section • Use up to a maximum of four levels to break up information. Example: 1. Cardiovascular Disease A. Etiology i. Behavioural Ensure: • Clear chunking (grouping) of information: use sequential arrangement or bundling • Ensure standardized usage of formatting indicators such as type sizes and weights (e.g. bold) • Consider structuring by dividing patients into specific subclasses, if relevant 27 • Group specific recommendations near the summary of key evidence for those recommendations • Consider using bold and/or underline to draw attention to all recommendations, or, if applicable, to a subset of recommendations pertaining to the main PICO question(s) covered by the guideline • Report recommendations in a way that is visible and easy to find (i.e. do not embed recommendations within long paragraphs, and consider grouping recommendations in a summary section) r r Present information in an expected and clinically relevant order (match the guideline to the real world) Use: a stepwise approach, which presents information in small steps that are matched to the order of actual patient care (from the initial evaluation or presenting complaint to return to function) 28 . Grouping/ordering: Bundling information can reduce effort required to remember a list of recommendations, given limited memory span. 4 r r When a single recommendation or set of recommendations contains many different types of guidance, bundle similar types of guidance together Example: If a set of recommendations calls for a total of nine different actions: • Present them in three bundles of three items 4 • Bundle according to type of guidance (e.g. medical tests and procedures in one bundle, pharmacotherapeutic recommendations in another bundle, non-pharmacotherapeutic recommendation in another bundle)

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The Guideline Language and Format Instrument (GLAFI) Copyright Ó 2021: Gupta S and Kastner M Information Visualization: Refers to the visual representation or display of information to enhance usability. 28 r r Replace text explanations with images that can simplify complex information or are more self-explanatory than wordy 24,29 r r Flowcharts (also called "algorithms") Use flowcharts when decision logic is complex and the temporal sequence of events unclear, to 30 : • Optimally represent clinical decision pathways or complex information • Pictorially describe stepwise recommendations for patient care Ensure that any advice that may be seen as ambiguous or counter-intuitive is addressed within the flowchart, through footnotes, or through references to specific sections of the guideline text 5 Avoid translating all text information into a flowchart because of its condensed nature r r Graphs enhance interpretation and clarity of the recommendations in an intuitive way 31 When using graphs, choose the best style for the data you are presenting: • Horizontal bars are best for comparing categorical data (e.g., age group, race, sex, etc.) • Vertical bars are best for comparing ordinal data (e.g., blood group, performance, etc.) • Stacked bar graphs are better at conveying absolute risk • Simple bar graphs are better at conveying relative risk • Line graphs are best when illustrating the effectiveness of a drug or trends over time (e.g., survival/mortality) r r Tables improve clarity and make documents easier to read) 32,33 ** Optimized Use basic colours: yellow, blue green, red, and black; yellow and blue are best for people who are colour blind Avoid the colours: pink, gray, orange, brown or purple Apply a consistent colour palette throughout the document: use the same colours and use those colours in the same way (for emphasis, ordering, etc.) in different sections of the guideline r r Ensure high contrast 34 ** Place a thin white or black border around any graphical elements containing coloured shapes in order to enhance contrast Avoid gray scales, which are very unreliable as a method of conveying contrast, particularly for quantitative information r r Use bulleted lists to simplify and clarify a series of points, and to deal with repetition or complex paragraph structures** If there are five or more bullets: consider breaking them into sub-groups of related items 35 Avoid numbered lists as this can imply a ranking or preference that may not be intended 35 Avoid transition words within bullets. 35 For example: